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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.
FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa
"Vyjuvek is the first FDA-approved gene therapy treatment for Dystrophic Epidermolysis Bullosa a rare and serious genetic skin disorder," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Today's action demonstrates the FDA's ongoing commitment to supporting the development and evaluation of new treatments that address unmet needs for rare diseases or conditions."
Abbott Receives FDA Approval for TactiFlex™ Ablation Catheter for Treatment of Abnormal Heart Rhythm
The TactiFlex™ Ablation Catheter, Sensor Enabled™, the world's first ablation catheter with a flexible tip and contact force technology.
The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway
If granted, MIRA surgical system will become the first robotic-assisted surgery device to obtain marketing authorization through the De Novo pathway for use in bowel resection procedures, making it a trailblazer in soft tissue robotics. Beyond granting Virtual Incision the ability to commercialize MIRA in the U.S. for its intended use, an authorization may lay the foundations for expanded procedural indications, entry into international markets, additional instruments and accessories, and future generations of the surgical system
BD Gains 510(k) Clearance of Artificial Intelligence Software for MRSA Diagnostics
The MRSA imaging application uses AI algorithms to look for specific culture characteristics on the BBL™ CHROMagar™ MRSA II plate. Based on that information and analysis by BD Synapsys™ informatics, plate images are automatically organized and sorted into meaningful worklists for laboratory scientists and technicians.
Hubly Surgical Receives 510k Clearance from FDA to Market Innovative Cranial Access Drill for Neurosurgical Safety in the ICU
The Hubly Drill aims to mitigate the challenges of bedside cranial access by being the first and only cordless single-use cranial drill with advanced features for safety and efficiency in any setting. "Essentially we are bringing the precision of the operating room, which physicians are accustomed to, to the bedside," said Founder/CEO Casey Grage.
Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for Epidural Injections
Omeq Medical CEO, Lior Margalit remarked, "We are grateful to the anesthesia community that has supported our development. We now turn our focus to bring EpiFinder to US patients receiving epidural injections. EpiFinder offers the potential to become the new standard of care while performing LOR.
HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System
The INTEGRATE-C™ system offers a multitude of sizes and lordotic angles to accommodate patient anatomy. The company's commercialization strategy is presently focused on a limited user release to establish efficacy with clinical data notes HAPPE Spine.
Norlase Receives FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser
The ECHO™ Green Pattern Laser nd scanner are completely integrated into a single delivery device that attaches to compatible slit lamps.